Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery

NCT ID: NCT04657874

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-27

Brief Summary

A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery following surgery periodontal and implant surgery.

Detailed Description

At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to perform one of the interventions described above and that fall within the criteria of inclusion.

The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies and will be initiated with the approval of the Internal Review Board of the University of L'Aquila.

The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be recorded on the data base clinicaltrials.gov.

Conditions

Postoperative Pain; Edema; Swelling Lips & Face

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Bromelain and Escin

Group Type: ACTIVE_COMPARATOR

Bromelains and Escin Oral Tablet

Intervention Type: OTHER

Supportive care after oral surgery

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral tablet without the active principle

Interventions

Bromelains and Escin Oral Tablet

Supportive care after oral surgery

Intervention Type: OTHER

Placebo

Oral tablet without the active principle

Intervention Type: OTHER

Other Intervention Names

Noflogo®

Eligibility Criteria

Inclusion Criteria

• No signs of gingival inflammation;
• FMBS and FMPS ≤ 20% after non-surgical causal therapy (Only for patients undergoing periodontal surgery)
• Smokers have to indicate how many cigarettes they smoke and how long have they been smoking

Exclusion Criteria

• Gingival inflammation
• Positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological)
• Treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial
• History of allergy to one or more components of the medication to be tested
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Leonardo Mancini

UNKNOWN

Sponsor Role: collaborator

Tommaso Pizzolante

UNKNOWN

Sponsor Role: collaborator

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Enrico Marchetti

Prof. Enrico Marchetti

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of L'Aquila, Division of Periodontology

L’Aquila, AQ, Italy

Countries

Italy

Other Identifiers

RCT 002/2017

Identifier Type: -

Identifier Source: org_study_id